关于诺诚健华医药有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 诺诚健华医药有限公司 目 录 | 一、非经营性资金占用及其他关联资金往来情况的专项说明 | 1 - 2 | | --- | --- | | 二、非经营性资金占用及其他关联资金往来情况汇总表 | 3 - 4 | 页 次 Frnst & Young Hua Ming | I P Level 17 Frnst & Young Towe ental Plaza, 1 Fast Chang An Avent eiling, China 100738 安永华明(2025) 专字第70045495 A02号 诺诚健华医药有限公司 诺诚健华医药有限公司董事会: 我们审计了诺诚健华医药有限公司的2024年度财务报表,包括2024年12月31日的 合并资产负债表,2024年度的合并利润表、股东权益变动表和现金流量表以及相关财 务 报 表 附 注,并 于 2025 年 3 月 27 日 出 具 了 编 号 为 安 永 华 明 ( 2025 ) 审 字 第 70045495 A01号的无保留意见审计报告。 按照《上市公司监管指引第8号 -- 上市 ...

诺诚健华医药有限公司 2024年度募集资金存放与实际使用情况鉴证报告 募集资金存放与实际使用情况鉴证报告 安永华明（2025）专字第70045495_A01号 诺诚健华医药有限公司 诺诚健华医药有限公司董事会： 我们接受委托，对后附的诺诚健华医药有限公司2024年度募集资金存放与实际使 用情况的专项报告（"募集资金专项报告"）进行了鉴证。按照《上市公司监管指引 第2号——上市公司募集资金管理和使用的监管要求》、《上海证券交易所科创板上市 公司自律监管指引第1号——规范运作》及相关格式指南编制募集资金专项报告，并保 证其内容真实、准确、完整，不存在虚假记载、误导性陈述或重大遗漏是诺诚健华医 药有限公司董事会的责任。我们的责任是在执行鉴证工作的基础上对募集资金专项报 告独立发表鉴证意见。 诺诚健华医药有限公司 目 录 | | 页 次 | | --- | --- | | 一、募集资金存放与实际使用情况鉴证报告 | 1 - 2 | | 二、募集资金存放与实际使用情况的专项报告 | 3 - 8 | 我们按照《中国注册会计师其他鉴证业务准则第3101号——历史财务信息审计或 审阅以外的鉴证业务》的规定执行了鉴证业务。该准 ...

诺诚健华医药有限公司 董事会审核委员会 2024 年度履职报告 根据《上海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》、 公司章程及公司制定的《审核委员会章程》等有关规定，2024 年度，诺诚健华医 药有限公司（以下简称"公司"）董事会审核委员会（以下简称"审核委员会"）勤 勉尽责，积极履行审核委员会的工作职责，现将审核委员会 2024 年度的履职情 况汇报如下： 一、审核委员会基本情况 截至 2024 年 12 月 31 日，公司审核委员会由三名董事组成，包括公司的独 立非执行董事与非执行董事，分别为胡兰女士、谢榕刚先生、董丹丹博士，其中 胡兰女士担任委员会主席。 报告期内，因作为中国科学院院士，为投入更多时间致力于学术研究，陈凯 先博士申请辞去公司独立非执行董事、董事会审核委员会成员、董事会薪酬委员 会成员、董事会提名委员会成员职务。公司于 2024 年 9 月 25 日召开董事会，审 议通过了委任独立非执行董事董丹丹博士担任董事会审核委员会成员。 二、审核委员会年度会议召开情况 2024 年度，公司审核委员会共召开 5 次会议，全体委员均出席全部会议。 具体会议召开及议案审议情况如下： ...

根据公司《审核委员会章程》等有关规定，审核委员会对会计师事务所履 行监督职责的情况如下： 安永华明于 1992 年 9 月成立，2012 年 8 月完成本土化转制，从一家中外合 作的有限责任制事务所转制为特殊普通合伙制事务所。安永华明总部设在北京， 注册地址为北京市东城区东长安街 1 号东方广场安永大楼 17 层 01-12 室。截至 2024 年末拥有合伙人 251 人，首席合伙人为毛鞍宁先生。安永华明一直以来注 重人才培养，截至 2024 年末拥有执业注册会计师逾 1,700 人，其中拥有证券相 关业务服务经验的执业注册会计师超过 1,500人，注册会计师中签署过证券服务 业务审计报告的注册会计师逾 500 人。 （二）聘请会计师事务所履行的程序 2024 年 3 月 28 日，公司召开审核委员会及董事会，审议通过了《续聘核数 师》的议案，同意公司续聘安永会计师事务所作为公司 2024 年度港股核数师， 续聘安永华明作为公司 2024 年度 A 股审计机构，该事项后经 2024 年 3 月 28 日 董事会审议通过，并于 2024 年 6 月 27 日经 2024 年股东周年大会审议通过。 诺诚健华医药有 ...

Financial Performance - The company reported a net loss of 453 million yuan for the fiscal year 2024, with a cash-adjusted loss of 431 million yuan after excluding non-cash items[3]. - The company will not distribute profits for the fiscal year 2024, pending approval at the annual shareholders' meeting[8]. - The company reported a total revenue of RMB 1.2 billion for the fiscal year 2024, representing a year-over-year increase of 15%[20]. - The net loss attributable to shareholders decreased by 30.20% year-on-year, amounting to approximately RMB 440.63 million in 2024, compared to RMB 631.26 million in 2023, due to increased sales of the drug Orelabrutinib and reduced foreign exchange losses[32]. - The net cash outflow from operating activities improved significantly, decreasing from RMB 665.49 million in 2023 to RMB 365.55 million in 2024, attributed to increased sales and cash receipts from goods sold[32]. - The company reported a gross margin of 60% for the fiscal year 2024, an improvement from 55% in the previous year[20]. - Operating expenses were reduced by 10% year-over-year, contributing to improved profitability[20]. - The adjusted net loss for the year, excluding certain non-cash items, was RMB 430.80 million, compared to RMB 490.67 million in the prior year, reflecting a decrease of about 12%[41]. Research and Development - Research and development expenses increased by 7.57% year-on-year to 815 million yuan, reflecting the company's ongoing investment in new technology platforms and clinical trials[3]. - The company is investing RMB 200 million in R&D for new technologies, focusing on enhancing product efficiency and user experience[20]. - Research and development expenses accounted for 80.70% of total revenue in 2024, a decrease of 21.83 percentage points from 102.53% in 2023, reflecting the substantial growth in revenue[31]. - The company has established a comprehensive research and development platform to accelerate drug discovery and improve clinical trial efficiency[49]. - The company is engaged in developing innovative small molecules, monoclonal antibodies, and bispecific antibodies targeting promising indications in hematological malignancies and solid tumors[88]. Product Pipeline and Approvals - The company has a robust product pipeline in hematological malignancies, autoimmune diseases, and solid tumors, with its core product, Orelabrutinib, already commercialized[4]. - The BLA for the Tafasitamab and Lenalidomide combination therapy has been accepted by the CDE and is under priority review, expected to receive approval in the first half of 2025[4]. - The company has multiple products in various stages of clinical trials, with several expected to advance to market approval by mid-2025, including Tafasitamab combined with Lenalidomide for treating relapsed or refractory DLBCL[46]. - The company aims to establish a leadership position in the hematological oncology field, focusing on treatments for Non-Hodgkin Lymphoma (NHL), leukemia, and multiple myeloma (MM)[47]. - The company aims to establish a competitive drug portfolio for the treatment of various solid tumors, utilizing targeted therapies, immuno-oncology methods, and advanced ADC technology[78]. Market Expansion and Strategy - The company expects revenue guidance for 2025 to be between RMB 1.5 billion and RMB 1.7 billion, indicating a growth rate of 25% to 42%[20]. - Market expansion plans include entering two new international markets by Q3 2025, aiming for a 10% market share in each[20]. - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of up to RMB 500 million allocated for this purpose[20]. - A strategic partnership with a leading tech firm is expected to enhance distribution channels and increase market penetration by 30%[20]. - The company plans to continue expanding its market presence and product offerings, focusing on the ongoing development of innovative therapies[32]. Clinical Trials and Efficacy - The ORR for Tafasitamab combined with Lenalidomide in clinical trials was reported at 73.1%, with 32.7% of patients achieving CR[55]. - ICP-248, a new oral BCL-2 inhibitor, has shown promising results in early trials, with an ORR of 87.5% in r/r CLL/SLL patients[59]. - The company aims to complete the Phase III clinical trial for Obinutuzumab in ITP by the end of 2025 and submit the NDA in the first half of 2026[68]. - The Phase II clinical trial data for Obinutuzumab in ITP will be published in The American Journal of Hematology in April 2024, with a Phase III trial expected to complete in 2025[141]. - The ongoing clinical trials for ICP-490 and ICP-B05 are expected to further evaluate their safety and efficacy in various cancer indications[123][124]. Innovation and Technology - The company is leveraging its proprietary ADC platform to develop differentiated ADC products aimed at improving efficacy and safety in cancer treatment[49]. - The proprietary ADC platform features irreversible bioconjugation technology and a drug-antibody ratio (DAR) of 8, aiming to enhance stability and therapeutic efficacy[82]. - The ADC platform utilizes proprietary linker-payload technology, achieving a drug-antibody ratio (DAR) of 8, aimed at providing effective and targeted cancer therapies[175]. - The company has completed the IV formulation dose escalation for ICP-B02, which shows good efficacy in FL and DLBCL patients[117]. Management and Governance - The company’s management team has extensive experience from major pharmaceutical companies, enhancing its capabilities in drug development and commercialization[45]. - The company operates as a red-chip enterprise, listed on both the Hong Kong Stock Exchange and the Shanghai Stock Exchange's Sci-Tech Innovation Board[10]. Market Trends and Projections - The global pharmaceutical market size was $1.50 trillion in 2022 and is expected to reach approximately $2.09 trillion by 2030[189]. - The global oncology drug market size grew from $143.5 billion in 2019 to $228.9 billion in 2023, with a CAGR of 12.4%, and is projected to reach $419.8 billion by 2030, with a CAGR of 9.1% from 2023 to 2030[197]. - The global autoimmune disease treatment market is projected to reach $185 billion by 2029, with a compound annual growth rate (CAGR) of 3.7%[66].

一、主要会计数据和财务指标 | 名称 | 持有数量(万股) | 占总股本比例 | 增减情况(万 | | --- | --- | --- | --- | | | | (%) | 股) | | HKSCC NOMINEES LIMITED | 85769.22 | 48.66 | 0.10 | | HHLR Fund, L.P.及其一致行动人 | 20867.12 | 11.84 | 不变 | | King Bridge Investments Limited及其一致行动人 | 15858.86 | 9.00 | 不变 | | Sunny View Holdings Limited与Renbin Zhao(赵仁 滨)家族 | 14471.79 | 8.21 | 不变 | | Sunland BioMed Ltd与Jisong Cui(崔霁松)家族 | 12660.03 | 7.18 | 不变 | | 鹏华医药科技股票A | 1880.49 | 1.07 | -34.57 | | 富国精准医疗灵活配置混合A | 1282.34 | 0.73 | 不变 | | 易方达医疗保健行业混合A | 916.34 | 0.52 ...

InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 諾誠健華醫藥有限公司 （「本公司」） 提名委員會職權範圍 InnoCare Pharma Limited 諾誠健華醫藥有限公司 1. 就本職權範圍（「職權範圍」）而言： 董事會指本公司的董事會。 財務總監指董事會不時委任負責財務管理的本公司高級行政人員。 公司秘書指本公司的公司秘書。 董事指董事會成員。 本集團指於有關期間，本公司及其附屬公司和聯營公司；或若文義另有 所指，於本公司成為其現時附屬公司和聯營公司的控股公司前期間，本公 司現時附屬公司和聯營公司；或其現時附屬公司和聯營公司或其前身（視 乎具體情況）所營運的業務。 上市規則指《香港聯合交易所有限公司證券上市規則》（經不時修訂）。 提名委員會指董事會根據本職權範圍第2條通過的決議案而設立的提名委 員會。 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 提名委員會職權範圍 定義 – 1 – 高級管理層指主席、行政總裁、首席醫學官、首席財務官、首席技術官及 本公 ...

诺诚健华医药有限公司 关于召开 2024 年度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： | A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-007 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 会议召开时间：2025 年 3 月 28 日(星期五)上午 11:00-12:00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2025 年 3 月 21 日(星期五)至 3 月 27 日(星期四)16:00 前登录 上 证 路 演 中 心 网 站 首 页 点 击 " 提 问 预 征 集 " 栏 目 或 通 过 公 司 邮 箱 IR@innocarepharma.com 进行提问。公司将在说明会上对投资者普遍关注的问题 进行回答 诺诚健华医药有限公司（以下简 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking it as the first coverage [4]. Core Viewpoints - The company is positioned as a leader in the domestic blood cancer drug market, with continuous innovation driving steady growth. It has a strong pipeline of products in development and is expected to expand its commercial offerings significantly in the near future [8][15]. - The company has successfully raised a total of $1.34 billion through multiple funding rounds from 2020 to 2022, which has been directed towards enhancing research and development efforts [8][15]. - The company is expected to achieve revenues of 1.01 billion yuan in 2024, representing a year-on-year growth of 36.8%, with a projected net loss of 444 million yuan, a reduction of approximately 30% compared to the previous year [8][15]. Financial Summary - **Revenue Forecasts**: - 2022: 625 million yuan - 2023: 739 million yuan - 2024E: 1,010 million yuan - 2025E: 1,442 million yuan - 2026E: 1,797 million yuan - **Growth Rates**: - 2023: 18.1% - 2024E: 36.8% - 2025E: 42.7% - 2026E: 24.7% [8][15]. - **Net Profit Forecasts**: - 2022: -887 million yuan - 2023: -631 million yuan - 2024E: -444 million yuan - 2025E: -300 million yuan - 2026E: -214 million yuan [8][15]. - **Return on Equity (ROE)**: - 2022: -11.7% - 2023: -9.0% - 2024E: -6.7% - 2025E: -4.8% - 2026E: -3.5% [8][15]. Product Pipeline - The company has 13 products in development, with two already commercialized. The pipeline includes several products that are expected to enter the market soon, such as ICP-723 and various indications for Obinutuzumab [8][23]. - The company is focusing on blood cancers, autoimmune diseases, and solid tumors, with a significant number of products in late-stage clinical trials [8][23]. Market Position - The company is recognized as the fifth A+H listed pharmaceutical company in China, with a management team that possesses extensive experience in drug development and commercialization [15][19]. - The company has established a strong market presence through its lead product, Obinutuzumab, which has been pivotal in its revenue growth since its launch [8][15].